Bristol-Myers Squibb and Pfizer have announced the start of a new Phase III trial to assess the effect of apixaban in patients with venous thromboembolism, a potentially fatal disease process that begins with blood clots in the leg veins or lungs.

Apixaban, which is currently being developed by the two companies, is an investigational oral, highly selective factor Xa inhibitor, a new class of agents with therapeutic potential to prevent and treat blood clots. The AMPLIFY trials are part of the EXPANSE programme - the global Phase III project for the drug and added to AMPLIFY-EXT, these two trials involve approximately 7,300 patients.

The initiation of this new apixaban trial represents the firm's commitment "to furthering research in the treatment of VTE, a serious disease that affects 1.3 million people annually in the USA and Europe,” said Jack Lawrence, vice president of R&D at B-MS. he added that current oral drug treatment options for the treatment of patients with VTE are primarily vitamin K antagonists, such as warfarin. but the limitations of VKAs include "a slow onset of action, a narrow therapeutic window necessitating regular coagulation monitoring and dose adjustment and multiple food and drug interactions.”

Meantime, Germany's Merck KGaA has signed an agreement with B-MS to sell more than 30 of the latter's prescription drugs in Latin America, the German company said on Tuesday.

The Darmstadt-headquartered firm said that its Merck Serono unit has acquired the exclusive rights to market the drugs in seven Latin American countries. Financial terms of the deal were not disclosed but the firms noted that sales for this portfolio of products exceeded $90 million in 2007. Among the drugs included in the agreement are the cholesterol-lowerer Pravachol (pravastatin) and the antihypertensive Monopril (fosinopril).